Medtronic receives FDA clearance for new InPen™ app, paving the way for its Smart MDI system launch with Simplera™ CGM
Medtronic (NYSE: MDT) has received FDA clearance for its new InPen™ app with missed meal dose detection, enabling the launch of its Smart MDI system with Simplera™ CGM. The system combines a smart insulin pen with a new disposable CGM that's 50% smaller than previous versions. This marks the first system to provide real-time, personalized recommendations for missed or inaccurate insulin doses. The technology addresses a critical need, as patients typically miss 1 in 3 insulin doses. The company plans a phased rollout, starting with existing CGM and InPen™ customers before a broader commercial launch.
Medtronic (NYSE: MDT) ha ricevuto l'approvazione della FDA per la sua nuova app InPen™ con rilevamento delle dosi di insulina perse, permettendo il lancio del suo sistema Smart MDI con Simplera™ CGM. Il sistema combina una penna per insulina intelligente con un nuovo CGM usa e getta che è il 50% più piccolo rispetto alle versioni precedenti. Questo segna il primo sistema in grado di fornire raccomandazioni personalizzate in tempo reale per dosi di insulina mancanti o imprecise. La tecnologia risponde a un'esigenza critica, dato che i pazienti di solito saltano 1 dose di insulina su 3. L'azienda prevede un lancio graduale, partendo dai clienti esistenti di CGM e InPen™ prima di una commercializzazione più ampia.
Medtronic (NYSE: MDT) ha recibido la autorización de la FDA para su nueva app InPen™ con detección de dosis de comida omitidas, lo que permite el lanzamiento de su sistema Smart MDI con Simplera™ CGM. El sistema combina un bolígrafo de insulina inteligente con un nuevo CGM desechable que es un 50% más pequeño que las versiones anteriores. Este es el primer sistema que proporciona recomendaciones personalizadas en tiempo real para dosis de insulina omitidas o inexactas. La tecnología aborda una necesidad crítica, ya que los pacientes suelen omitir 1 de cada 3 dosis de insulina. La empresa planea un lanzamiento gradual, comenzando con los clientes existentes de CGM y InPen™ antes de un lanzamiento comercial más amplio.
메드트로닉 (NYSE: MDT)는 새로운 InPen™ 앱에 대한 FDA 승인을 받았으며, 이는 놓친 식사 용량을 감지하여 Simplera™ CGM과 함께 스마트 MDI 시스템의 출시를 가능하게 합니다. 이 시스템은 이전 버전보다 50% 더 작은 새로운 일회용 CGM과 스마트 인슐린 펜을 결합합니다. 이는 놓치거나 부정확한 인슐린 용량에 대한 실시간 개인화된 추천을 제공하는 최초의 시스템입니다. 이 기술은 환자가 일반적으로 3회 중 1회의 인슐린 용량을 놓치는 중요한 필요성을 해결합니다. 회사는 기존 CGM 및 InPen™ 고객부터 시작하여 더 넓은 상업적 출시 전 단계적인 롤아웃을 계획하고 있습니다.
Medtronic (NYSE: MDT) a reçu l'approbation de la FDA pour sa nouvelle application InPen™ avec détection des doses de repas manquées, permettant le lancement de son système Smart MDI avec Simplera™ CGM. Le système combine un stylo à insuline intelligent avec un nouveau CGM jetable qui est 50 % plus petit que les versions précédentes. C'est le premier système à fournir des recommandations personnalisées en temps réel pour des doses d'insuline manquées ou inexactes. La technologie répond à un besoin critique, car les patients manquent généralement 1 dose d'insuline sur 3. L'entreprise prévoit un déploiement progressif, en commençant par les clients existants de CGM et InPen™ avant un lancement commercial plus large.
Medtronic (NYSE: MDT) hat die FDA-Zulassung für ihre neue InPen™-App mit Erkennung versäumter Mahlzeiten-Dosen erhalten, die den Start ihres Smart MDI-Systems mit Simplera™ CGM ermöglicht. Das System kombiniert einen intelligenten Insulinpen mit einem neuen Einweg-CGM, das 50% kleiner ist als frühere Versionen. Dies markiert das erste System, das in Echtzeit personalisierte Empfehlungen für versäumte oder ungenaue Insulindosen bietet. Die Technologie spricht ein kritisches Bedürfnis an, da Patienten typischerweise 1 von 3 Insulindosen auslassen. Das Unternehmen plant einen schrittweisen Rollout, beginnend mit bestehenden CGM- und InPen™-Kunden, bevor eine breitere kommerzielle Einführung erfolgt.
- First-to-market technology for real-time insulin dose correction recommendations
- FDA clearance received for new InPen™ app
- Simplera™ CGM is 50% smaller than previous versions
- Addresses significant market need with 1-in-3 doses typically missed by patients
- initial market release restricting immediate revenue potential
- Phased rollout approach may slow market penetration
Insights
The FDA clearance of Medtronic's enhanced InPen™ app represents a significant technological advancement in diabetes management. The Smart MDI system's integration with Simplera™ CGM addresses a critical market gap, particularly considering that
The system's unique ability to detect and recommend corrections for missed doses positions it as a first-to-market innovation. The Simplera™ CGM's reduced size and all-in-one design should drive patient adoption, while the real-time dosing insights could improve treatment adherence and outcomes. Market impact should be substantial given Medtronic's established presence in diabetes care and the large addressable market of MDI therapy users.
This product launch strengthens Medtronic's competitive position in the $27 billion diabetes care market. The timing is strategic as the diabetes tech sector sees increasing demand for smart, connected devices. The phased rollout approach, starting with existing customers, indicates a careful market penetration strategy that could help ensure successful adoption and minimize launch risks.
The system's ability to reduce complications and potentially lower healthcare costs, as supported by clinical evidence, should appeal to both payers and providers. This could accelerate insurance coverage and market uptake, potentially driving meaningful revenue growth in Medtronic's diabetes segment.
New Smart MDI system will be the first system to deliver real-time, personalized insights on when and how much to dose including for missed or inaccurate mealtime doses.
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With this clearance, the system will be the first in the market to recommend corrections for missed or inaccurate insulin doses, providing real-time, personalized insights for individuals on multiple daily injection (MDI) therapy.
For people with diabetes who need daily insulin injections, bolusing before a meal is essential as it helps regulate glucose levels and prevent blood sugar spikes after eating. Minimizing the frequency of these glucose highs reduces the risk of both short- and long-term complications and supports better overall health. However, it's estimated that individuals living with diabetes regularly miss 1 out of 3 doses. The Missed Dose alert function helps to minimize the frequency of these glucose highs.1 The Medtronic Smart MDI system reduces the guesswork out of diabetes management, helping to address a significant unmet need for MDI users who struggle with juggling numerous decisions related to insulin dosing on a daily basis.
"I'm thrilled about the launch of the Medtronic Smart MDI system with the InPen™ app and Simplera™ CGM. This is a significant leap forward for those on multiple daily injections, offering intelligent dosing insights and simplifying diabetes management," said Diana Isaacs, PharmD, BCPS, BCACP, BC-ADM, CDCES, FADCES, FCCP. "By reducing the guesswork out of insulin dosing, this tool helps maintain stable blood sugars, optimize long-term health, and reduce complications from hyperglycemia."2,3
Medtronic will initiate a limited market release beginning with existing standalone CGM and InPen™ customers followed by a broad commercial launch.
1. MacLeod, J, Heungyong Im, G, Smith, M, Vigersky, RA. Shining the Spotlight on Multiple Daily Insulin Therapy: Real-World Evidence of the InPen Smart Insulin Pen. Diabetes Technology & Therapeutics. 2024. 26:1, 33-39. |
2. Vigersky et al., Impact Of InPen Smart Insulin Pen Use on Real-World Glycemic and Insulin Dosing Outcomes in Individuals with Poorly Controlled Diabetes. Presented at: American Diabetes Association; 81st Scientific Sessions; 2021 Jun 25-29. |
3. Chien A, Thanasekaran S, Gaetano A, Im G, Wherry K, MacLeod J, Vigersky RA. Potential cost savings in |
About the Diabetes Business at Medtronic (www.medtronicdiabetes.com)
Medtronic Diabetes is on a mission to alleviate the burden of diabetes by empowering individuals to live life on their terms, with the most advanced diabetes technology and always-on support when and how they need it. We've pioneered first-of-its-kind innovations for over 40 years and are committed to designing the future of diabetes management through next-generation sensors (CGM), intelligent dosing systems, and the power of data science and AI while always putting the customer experience at the forefront.
About Medtronic
Bold thinking. Bolder actions. We are Medtronic. Medtronic plc, headquartered in Galway,
Any forward-looking statements are subject to risks and uncertainties such as those described in Medtronic's periodic reports on file with the Securities and Exchange Commission. Actual results may differ materially from anticipated results.
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SOURCE Medtronic plc
FAQ
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